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Single Use Electrodes Sterile - 6 pcs

FDA UDI

Class II (US FDA UDI)

by Scibase AB

Identity

Trade Name
Single Use Electrodes Sterile - 6 pcs FDA UDI
Generic Name
Neoplasm electrical impedance spectrometer electrode array FDA UDI
Device Name
Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 times for a single patient on several lesions in a single procedure. FDA UDI
Model / Reference
131-0007 FDA UDI
Description
Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 times for a single patient on several lesions in a single procedure. FDA UDI

Identifiers

Catalog Number
131-0007 FDA UDI
Primary DI / UDI-DI
07350094440200 FDA UDI
PMA Number
P150046 FDA UDI
FDA Product Code
ONV FDA UDI
GMDN Term
Neoplasm electrical impedance spectrometer electrode array FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.1820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neoplasm electrical impedance spectrometer electrode array

Single Use Electrodes Sterile - 6 pcs by Scibase AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neoplasm electrical impedance spectrometer electrode array.

Cleared under the same submission

P150046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scibase AB

Sources (1)

  • FDA UDI 7c0384ee-1158-4bd2-a0f4-89bf9e2d67c7 35 fields · synced May 30, 2026